title: Hemodynamic outcomes of geometric ring annuloplasty for aortic valve repair: a 4-center pilot trial.
abstract: OBJECTIVE
  A geometric annuloplasty ring could improve efficacy and stability of aortic valve repair. Toward this goal, a 1-piece 3-dimensional titanium annuloplasty ring with Dacron covering was developed and tested successfully in animals. The purpose of this study was to define hemodynamic outcomes with this device used as the annuloplasty component of human aortic valve repair.
  
  
  METHODS
  In a 4-center pilot trial with informed consent, 16 patients underwent aortic valve repair for aortic insufficiency, with the annuloplasty device sutured into the annulus beneath the leaflets. Preoperative annular diameter averaged 26.5 ± 2.0 (mean ± standard deviation) mm, and average ring size was 22.3 ± 1.2 mm. After annuloplasty, leaflet defects were easy to identify, and 14 of 16 patients (88%) required leaflet plication and/or autologous pericardial reconstruction for leaflet defects. Three patients had ascending aortic replacement, and 2 had remodeling root replacement. One had ultrasonic leaflet decalcification and another tricuspid valve annuloplasty. Follow-up data were from site-specific studies at the 6-month postoperative time point.
  
  
  RESULTS
  There were no in-hospital mortalities or major complications. Preoperative aortic insufficiency grade (0-4 scale) was 3.6 ± 1.0 and fell to 1.0 ± 0.8 at 6 months (P < .0001). New York Heart Association class fell from 2.5 ± 0.5 to 1.1 ± 0.3 (P < .0001). Postrepair valve area was 2.7 ± 0.2 cm(2), and 6-month mean systolic gradient was 11.3 ± 3.3 mm Hg. Left ventricular end-diastolic diameter and ejection fraction both normalized (both P < .0001).
  
  
  CONCLUSIONS
  Geometric ring annuloplasty facilitated aortic valve repair, allowing more precise reconstruction of leaflet defects. Aortic insufficiency reduction and systolic gradients were excellent, and expansion of valve reconstruction into broader categories of aortic valve disease seems indicated.
authors.affiliation: German Heart Center Munich, Department of Cardiovascular Surgery, Technische Universität München, Munich, Germany.
authors.forename: Domenico
authors.initials: D
authors.lastname: Mazzitelli
authors.affiliation: German Heart Center Berlin, Berlin, Germany.
authors.forename: Christof
authors.initials: C
authors.lastname: Stamm
authors.affiliation: Vanderbilt University, Nashville, Tenn. Electronic address: jsrankinmd@cs.com.
authors.forename: J Scott
authors.initials: JS
authors.lastname: Rankin
authors.affiliation: German Heart Center Munich, Department of Cardiovascular Surgery, Technische Universität München, Munich, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Nöbauer
authors.affiliation: Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Pirk
authors.affiliation: Department of Cardiovascular Diseases, Katholieke Universiteit Leuven, Leuven, Belgium.
authors.forename: Bart
authors.initials: B
authors.lastname: Meuris
authors.affiliation: Vanderbilt University, Nashville, Tenn.
authors.forename: Philip S
authors.initials: PS
authors.lastname: Crooke
authors.affiliation: German Heart Center Munich, Department of Cardiovascular Surgery, Technische Universität München, Munich, Germany.
authors.forename: Anke
authors.initials: A
authors.lastname: Wagner
authors.affiliation: BioStable Science and Engineering Inc, Austin, Tex.
authors.forename: L Alan
authors.initials: LA
authors.lastname: Beavan
authors.affiliation: BioStable Science and Engineering Inc, Austin, Tex.
authors.forename: Charles D
authors.initials: CD
authors.lastname: Griffin
authors.affiliation: BioStable Science and Engineering Inc, Austin, Tex.
authors.forename: Debby
authors.initials: D
authors.lastname: Powers
authors.affiliation: German Heart Center Berlin, Berlin, Germany.
authors.forename: Boris
authors.initials: B
authors.lastname: Nasseri
authors.affiliation: German Heart Center Munich, Department of Cardiovascular Surgery, Technische Universität München, Munich, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Schreiber
authors.affiliation: German Heart Center Berlin, Berlin, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Hetzer
authors.affiliation: German Heart Center Munich, Department of Cardiovascular Surgery, Technische Universität München, Munich, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D058385:Cardiac Valve Annuloplasty / Q000295:instrumentation*; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011093:Polyethylene Terephthalates; D011474:Prosthesis Design; D020127:Recovery of Function; D012720:Severity of Illness Index; D013997:Time Factors; D014025:Titanium; D016896:Treatment Outcome
chemical_list: D011093:Polyethylene Terephthalates; D014025:Titanium